The Director, External Funding Compliance will serve as the process owner and compliance business partner to all functions involved in the External Funding process (e.g. Global Medical Affairs, Patient Advocacy, Corporate Social Responsibiity etc.) . In collaboration with appropriate business functions, this role will assist in the creation of governance around the External Funding process such as establishing organizational giving priorities, setting budgets, and evaluating requests for external funding consistent with organizational priorities. This role will be responsible for managing the grants review system, developing, updating and maintaining expertise on interal policies and SOPs, as well as demonstrating a strong expertise on the compliance risks associated with external funding activities. This role will maintain a focus on the external environment, ensuring that our policies and practices reflect industry standards and guidelines. This role will convene and lead regular meetings of the various review committees, create and drive the agenda, document decisions and serve as a key contact to manage communications to external applicants. This role will be responsible for continued process improvements and training of all stakeholders on the system, review process and their respective roles relative to each type of funding request. This role will also interface with the broader Compiance Department to help identify issues or concerns requiring local compliance input.
This position requires a skilled professional who demonstrates:
- Technical acumen in managing a web-based review system
- Compliance knowledge of issues impacting funding requests in the pharmaceutical industry
- Courage to speak up and raise concerns and openness to feedback from others
- Attention to detail in performing initial application reviews for completeness
- Organizational skills
- Excellent written and verbal communication skills
- Effective meeting management
- Influencing skills
- Manage the Grant Review System
- Convene and Manage Meetings of Review Committees for each external funding type
- Developing compliance policies and training for each external funding type
- Provide initial application review for completeness
- Raise any compliance issues associated with the external funding request or internal review process
- Support compliance investigations as assigned;
- Develop and maintain knowledge and understanding of: Alexion products, industry regulations and guidelines and enforcement environment.
- 10 years of professional experience (5-7 of which should be in the pharmaceutical industry in either Compliance, Regulatory, Medical Affairs, Clinical Operations or Legal)
- Up to 20% travel
- Excellent written and verbal communication skills and organization skills are required
- Must possess an in-depth knowledge and understanding of pharmaceutical industry regulations and guidelines (e.g. FDA, PhRMA Code, Federal Anti-Kickback, False Claims, etc.)
- BA/BS degree required
- JD or MBA preferred
Boston, MA, United States
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.